🏛️ Verified NIH Record • Updated 2026-08-22

Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer (NCT01327781)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

🩺 Plain-English Summary (8th-Grade Level)

This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (37 items) and avoid the listed exclusions (36 items).

Location: Mayo Clinic in Arizona — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Any of the following therapies prior to registration:
  • Chemotherapy =\< 3 weeks
  • Immunotherapy =\< 3 weeks
  • Biologic therapy =\< 3 weeks
  • Hormonal therapy =\< 3 weeks
  • Monoclonal antibodies =\< 3 weeks
  • Radiation therapy =\< 3 weeks
  • Anti-Her-2 directed therapy =\< 3 weeks
  • Prior endoxifen therapy
  • Prior history of:
  • Stroke =\< 6 months prior to registration

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

  • Mayo Clinic in Arizona — Scottsdale, Arizona
  • Mayo Clinic in Florida — Jacksonville, Florida
  • Mayo Clinic in Rochester — Rochester, Minnesota

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗